Biotech Daily Review: BioSimilar Drug Enters Trial
by Richard Daverman, PhD
Centient Biotech Investor
BioGeneriX AG and Neose Technology (NTEC) began the second Phase I trial of GlycoPEG-GCSF, which will be compared to Amgen’s (AMGN) Neulasta, the only currently approved long-acting granulocyte colony stimulating factor (GCSF). These drugs are given to cancer patients who suffer from neutropenia as a result of chemotherapy. BioGeneriX is a member of the ratiopharm Group of companies, a leading generic manufacturer in Germany, which is where the trial will be conducted. BioGeneriX concentrates on biotech generics (see Potential Trouble Ahead for Big Biotechs). Neose Technology moved 9 cents higher to $2.05.
Artes Medical (ARTE) requested FDA permission to put new information on the label of its injectable anti-wrinkle treatment, ArteFill. Based on a five-year study, Artes is seeking to be the first injectable dermal filler to claim that the effects of its product will last for five years. Artes climbed 40 cents to $8.30.
Encysive (ENCY) began treating patients in a Phase II trial of a hypertension drug candidate. The oral compound, TBC3711, will be given on a once-daily basis to 150 patients with resistant hypertension for 12 weeks. Four dosing levels are included in the double-blind trial. TBC3711 is a selective antagonist of the endothelin receptor, which mediates blood vessel constriction. Encysive says the compound is more selective and potent than Thelin, which Encysive markets for pulmonary arterial hypertension. Encysive was up 10 cents at $2.91.
Emergent BioSolutions (EBS) submitted an Investigational New Drug application for its Anthrax Immune Globulin drug candidate. The first clinical step will be to give the drug to 105 healthy volunteers to test its safety. Emergent already produces BioThrax, the only FDA-approved vaccine for anthrax infection. Emergent shot up $1.14 to end the session at $13.46.
Aegerion Pharma (AEGR) filed to raise $86 million in an IPO. Aegerion, which was founded in 2005, has an anti-cholesterol drug that inhibits microsomal triglyceride transfer protein (MTP), lowering the production of cholesterol and triglycerides in the liver and intestines. The company has two drugs in clinical development, one in Phase III and Phase II trials, the other in Phase II testing.
UCB (UCBJF.PK), a biotech company based in Belgium, received FDA permission to add another type of seizure on the label of Keppra, an adjunct treatment for seizures in epileptic adults and children aged six and higher. The new indication is for primary generalized tonic-clonic (PGTC) seizures. Generalized seizures account for 40% of all seizures and generalized tonic-clonic comprise 23%. This is the fourth indication for Keppra. UCB was listed at $62.35.
Illumina (ILMN) launched its BeadXpress System, based on the VeraCode digitial microbead technology. The system provides high-quality multiplexing capability and assay flexibility. It allows researchers to assay hundreds of analytes in a sample at one time. Duke University and Johns Hopkins University have already taken delivery of systems. Ilumina rose 67 cents to $30.30.
Cheered by the action of the Fed Open Market Committee, stocks moved broadly higher today, and biotech joined in. The Centient Biotech 200™ climbed 58 points to 3920, a gain of 1.50%. Today was the third day in a row the index has moved up, making the total increase this week 118 points or about 3%. The S&P 500 was 1.71% higher today, and Nasdaq saw a 1.98% gain.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: InterMune Retrenches
- Biotech Daily Review: AtheroGenics Tumbles On Drug Test Failure
- Biotech Weekly Review: Biotech Slides Slightly Lower
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Centient Biotech Investor
BioGeneriX AG and Neose Technology (NTEC) began the second Phase I trial of GlycoPEG-GCSF, which will be compared to Amgen’s (AMGN) Neulasta, the only currently approved long-acting granulocyte colony stimulating factor (GCSF). These drugs are given to cancer patients who suffer from neutropenia as a result of chemotherapy. BioGeneriX is a member of the ratiopharm Group of companies, a leading generic manufacturer in Germany, which is where the trial will be conducted. BioGeneriX concentrates on biotech generics (see Potential Trouble Ahead for Big Biotechs). Neose Technology moved 9 cents higher to $2.05.
Artes Medical (ARTE) requested FDA permission to put new information on the label of its injectable anti-wrinkle treatment, ArteFill. Based on a five-year study, Artes is seeking to be the first injectable dermal filler to claim that the effects of its product will last for five years. Artes climbed 40 cents to $8.30.
Encysive (ENCY) began treating patients in a Phase II trial of a hypertension drug candidate. The oral compound, TBC3711, will be given on a once-daily basis to 150 patients with resistant hypertension for 12 weeks. Four dosing levels are included in the double-blind trial. TBC3711 is a selective antagonist of the endothelin receptor, which mediates blood vessel constriction. Encysive says the compound is more selective and potent than Thelin, which Encysive markets for pulmonary arterial hypertension. Encysive was up 10 cents at $2.91.
Emergent BioSolutions (EBS) submitted an Investigational New Drug application for its Anthrax Immune Globulin drug candidate. The first clinical step will be to give the drug to 105 healthy volunteers to test its safety. Emergent already produces BioThrax, the only FDA-approved vaccine for anthrax infection. Emergent shot up $1.14 to end the session at $13.46.
Aegerion Pharma (AEGR) filed to raise $86 million in an IPO. Aegerion, which was founded in 2005, has an anti-cholesterol drug that inhibits microsomal triglyceride transfer protein (MTP), lowering the production of cholesterol and triglycerides in the liver and intestines. The company has two drugs in clinical development, one in Phase III and Phase II trials, the other in Phase II testing.
UCB (UCBJF.PK), a biotech company based in Belgium, received FDA permission to add another type of seizure on the label of Keppra, an adjunct treatment for seizures in epileptic adults and children aged six and higher. The new indication is for primary generalized tonic-clonic (PGTC) seizures. Generalized seizures account for 40% of all seizures and generalized tonic-clonic comprise 23%. This is the fourth indication for Keppra. UCB was listed at $62.35.
Illumina (ILMN) launched its BeadXpress System, based on the VeraCode digitial microbead technology. The system provides high-quality multiplexing capability and assay flexibility. It allows researchers to assay hundreds of analytes in a sample at one time. Duke University and Johns Hopkins University have already taken delivery of systems. Ilumina rose 67 cents to $30.30.
Cheered by the action of the Fed Open Market Committee, stocks moved broadly higher today, and biotech joined in. The Centient Biotech 200™ climbed 58 points to 3920, a gain of 1.50%. Today was the third day in a row the index has moved up, making the total increase this week 118 points or about 3%. The S&P 500 was 1.71% higher today, and Nasdaq saw a 1.98% gain.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: InterMune Retrenches
- Biotech Daily Review: AtheroGenics Tumbles On Drug Test Failure
- Biotech Weekly Review: Biotech Slides Slightly Lower
____________________
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